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OSHA Safety Hazard Information Bulletin on
Radioactive Contamination of Lead Shielding
June 24, 1997
The Illinois Department of Nuclear Safety (IDNS) and the Center for Devices and Radiological Health of the Food and Drug Administration (FDA) have brought to our attention that some lead used in shielding is contaminated with radionuclides and that products containing this lead were widely distributed throughout the country.
IDNS coordinated with FDA regarding the nature of the contamination. FDA on June 13, 1997 issued a public health notice entitled "Radioactivity in Radiation Protection Devices" to health care professionals. All compliance and consultative personnel should be aware that certain lead aprons, gonad shields, thyroid shields and other lead devices used by health care employees could be contaminated. FDA health notice is attached for your use and it includes background information and recommendations.
Please distribute this bulletin to all Area Offices, State Plan States, Consultation Project Offices, and appropriate labor and industry groups.
June 13, 1997
FDA PUBLIC HEALTH NOTICE
Radioactivity in Radiation Protection Devices
TO: Health Care Professionals
FDA is notifying you that some shielding products used for radiation protection contain lead contaminated with small amounts of naturally occurring radionuclides. The contaminants are lead-210 (Pb-210) and its daughter nuclides bismuth-210 (Bi-210) and poloniurn-210 (Po-210). Initial FDA and state evaluations indicate that there is only a very small exposure to radioactivity from the affected products, and the contaminants are not transferable to patients, personnel or equipment by ordinary use. The products identified to date include medical devices used for radiation protection such as lead aprons, gonad shields, and thyroid shields manufactured after October 1, 1996.
Standard radiation safety practice is to avoid unnecessary exposure to radiation. Therefore the use of contaminated products should be discontinued. However, in cases where no alternative shielding is available, continued use of the contaminated products will be likely to provide greater protection during therapeutic and diagnostic procedures than using no shielding. Facilities which have no alternative protective devices available should consider continued use of the contaminated items until replacements are obtained.
Investigations are underway to identify all firms that received contaminated lead. FDA and state radiation control program officials have determined that a shipment of contaminated tin-lead alloy was imported from Brazil and then processed by MIDCO Industries of St. Louis, MO. MIDCO sold contaminated lead to Taracorp Industries of Granite City, IL. Taracorp then manufactured contaminated lead powder which was sold to 19 firms. Some of these 19 firms manufactured or distributed contaminated lead or lead products to a number of companies, including medical device manufacturers.
Recalls are being initiated by medical device firms and distributors. To date, E-Z-EM of Portchester, NY, and Picker Corporation of Cleveland, OH, are voluntarily recalling contaminated products. Other manufacturer recalls are likely to follow. If you have purchased affected products, you should receive notice from your supplier. The notice should provide instructions for disposition or return of the devices, and may include replacement information. As affected product lists are available, they will be provided to the Conference of Radiation Program Control Directors and posted on the FDA's Internet site.
FDA recommends radiation protection medical devices containing lead purchased after October 1, 1996 be surveyed for radionuclide contamination. This should be done by qualified personnel a suitable survey meter, such as a thin window Geiger Mueller (G-M) instrument in contact with the product. The 1.16 MeV beta from the Bi-210 is easily detected with this type of instrument.
FDA requests users who discover shielding products with contaminated lead to report this information directly to MedWatch, the FDA's voluntary reporting program. Submit these reports to MedWatch by telephone at 1-800-FDA-1088, by FAX at 1-800-FDA-0178, or by mail to:
MedWatchContact Sherry Purvis-Wynn of FDA's Center for Devices and Radiological Health by E-mail firstname.lastname@example.org or by fax 301-594-2968 if you have any questions about this notice.
D. Bruce Burlington, M.D.
Center for Devices and Radiological Health
Footnote(1). The Directorate of Technical Support issues Hazard Information Bulletins (HlBs) in accordance with OSHA Instruction CPL 2.65 to provide relevant information regarding unrecognized or misunderstood health hazards, inadequacies of materials, devices, techniques, and engineering safety controls. HlBs are initiated based on information provided by the field staff, studies, reports and concerns expressed by safety and health professionals, employers, and the public. Information is compiled based on a through evaluation of available facts, literature and in coordination with appropriate parties. (Back to Text)